RadioMedix SPICA Center, a state-of-the-art facility provides contract development and manufacturing services for radiopharmaceutical companies, as well as products in its own pipeline. The company expects rapid growth and is looking for an experienced radiopharmacist to support and lead production activities. This key leadership position is a “hands-on” role that will interface with various functions at RadioMedix and collaborators to ensure timely, cost-effective development and manufacturing of radiopharmaceutical diagnostics and therapies for clinical supply and commercial launch.
Principal Responsibilities are:
- Oversee the execution of the organization’s contract manufacturing, outsourcing and/or in-sourcing relationships and opportunities
- Oversee capabilities for the company’s developmental candidates and the commercial product production
- Lead in-house and outsourced activities to develop and optimize processes for RadioMedix’s novel therapeutics or imaging agents
- Lead outsourced development and manufacturing activities for small molecule active pharmaceutical ingredients and/or precursors used in radiopharmaceutical products
- Responsible for production planning and managing supply chain
- Assist in SOP development, implementation, and revision
- Formulating and recommending manufacturing policies and programs
- Support the Quality Assurance unit during regulatory inspections
- Hire, supervise, and train new production staff, as needed
- Establish contract manufacturing partnerships with potential clients and manage tech transfer
- GMP manufacturing for clinical drug supply
- Technical writing and review of CMC related regulatory documents, SOPs, Quality Events, RFPs, etc
- Support other projects as needed
- Identify manufacturing and testing facilities for radiopharmaceuticals.
Education: Ph.D., Radiopharmacist
Experience: Candidates should have a minimum of 7-10 years relevant work experience.
Knowledge and experience in the following areas:
- Attentiveness to detail; strong communication and coaching skills; team-oriented focus; strong planning and organizational skills
- Manufacturing operations under cGMP compliance, aseptic processing, protein purification, process engineering, validation, technical writing, operations and maintenance of utility systems
- Experience with lutetium, Ga-68, alpha emitters radiopharmaceutical isotopes is highly desirable
- Ability to properly assess resources and plan accordingly
- Willing to travel when needed